I have extensive experience in NPI processes, having managed the introduction of several products from concept to market. This includes coordinating cross-functional teams, ensuring compliance with regulatory standards, and overseeing the entire product lifecycle. My role typically involves project management, risk assessment, and ensuring that all timelines and budgets are met.

I address challenges by first identifying the root cause and then collaborating with relevant stakeholders to develop a solution. For delays, I prioritize tasks, adjust timelines, and communicate transparently with all parties involved to ensure minimal impact on the overall project. My approach is to remain flexible and proactive in problem-solving.

I have utilized various tools and software such as Microsoft Project for project management, SAP for resource planning, and SolidWorks for design and engineering. Additionally, I am familiar with JIRA for issue tracking and Confluence for documentation, which are essential for maintaining clear communication and records throughout the NPI process.

I ensure compliance by staying updated on relevant regulations and standards, conducting regular audits, and working closely with legal and compliance teams. I also implement robust documentation practices and conduct thorough risk assessments to identify and mitigate potential issues early in the process.

One successful project I led involved the introduction of a new medical device. I coordinated a multidisciplinary team, managed the project timeline, and ensured all regulatory requirements were met. The product was launched on time, within budget, and received positive market reception, contributing significantly to the company's revenue growth.